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DOI: 10.1055/a-2306-9144
Efficiency and safety of nasal positive airway pressure systems during endoscopic procedures in high-risk patients: Endo-Breath study
Clinical Trial: Registration number (trial ID): NCT05972304, Trial registry: ClinicalTrials.gov (http://www.clinicaltrials.gov/), Type of Study: Prospective, Randomized, Single-Center
Background and study aims: Sedation of high-risk patients is a relevant issue in interventional endoscopy. This is especially because standard oximetric monitors display only hypoxia and not the preceding hypercapnia. Therefore, the question arises whether use of a nasal positive airway pressure (nPAP) system can decrease the rate of sedation-associated events. Patients and methods: A randomized, prospective trial was conducted at University Hospital Ulm, including 98 consecutive patients, identified as high-risk (American Society of Anesthesiologists physical status ≥ 3) and scheduled for prolonged (> 15 minutes) endoscopic procedures. Patients underwent 1:1 randomization to two groups: interventional (nPAP-Mask) and control (conventional oxygen supplementation). Levels of CO2 were measured noninvasively by transcutaneous capnometry device. The primary outcome was incidence of hypoxia (SpO2 < 90% over 10 seconds) and incidence of severe hypoxia was incidence of SpO<sub>2</sub>< 80% over 10 seconds. One of our secondary objectives was to determine if the nPAP-Mask could result in significant CO<sub>2</sub> retention among high-risk patients. <b>Results:</b> Data analysis showed lower incidence of hypoxia in the interventional group (10/47 vs. 31/251) <i>P</i> < 0.05. Episodes of severe hypoxia (SpO<sub>2</sub> < 80% over 10 seconds) were more frequent in the control group (8/51) compared with the intervention group (2/47) <i>P</i> < 0.05. There was no significant difference in ΔCO<sub>2</sub> levels in the interventional vs. control group (-6.01 ± 7.66 vs. -7.35 ± 8.59 mm Hg). <b>Conclusions:</b> In high-risk patients use of a nasal positive airway pressure system could significantly lower risk of hypoxia, especially in prolonged procedures. The nPAP-Mask does not induce CO<sub>2</sub> retention when compared with conventional oxygen supplementation.
Publication History
Received: 10 October 2023
Accepted after revision: 12 April 2024
Accepted Manuscript online:
15 April 2024
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